NCT05968482

Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants

A Phase 1, Single-Center, Randomized, Open-Label, Bioavailability and Safety Three Period Crossover Multiple-Dose Study Comparing Two Dose Levels of AMZ001 (Diclofenac Sodium Gel 3.06%) and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Amzell · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare drug exposure from two different products (AMZ001 and Diclofenac Sodium 1% Gel) in healthy participants on Day 7 after repeated topical administrations for 7 days. Participants will receive, in a crossover design, three different treatments * AMZ001 Low dose * AMZ001 High dose * Diclofenac Sodium 1% Gel Safety and tolerability of AMZ001 will be also investigated.

Detailed description

On their both knees, participants will apply once daily either low dose of AMZ001 or high dose of AMZ001 for 7 consecutive days. Participants will also apply Diclofenac Sodium 1% Gel as per label information on each knee. Intensive pharmacokinetic assessment (blood samplings) will be performed on the first day of application (Day 1) as well as on the last day of application (Day 7). Each participant will receive each of the three treatments in a randomized manner. Between each treatment, participant will not receive any of the three tested therapies between 3 weeks before receiving the next therapy. (washout period) Participants will stay on the clinical unit only during each period of treatment but not during washout period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Gel	Topical application on both knees

Timeline

• Start date: 2023-07-11
• Primary completion: 2023-12-27
• Completion: 2024-12-02
• First posted: 2023-08-01
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study